Photo by Sage Ross (ragesoss.com), from Wikimedia Commons. Creative Commons Attribution-Share Alike 3.0 Unported.
# 6814
A fascinating bit of research, published yesterday in JAMA Internal Medicine, looks at the effects of generic pill appearance on how dutifully patients will continue to take their medications.
While generic drugs must meet strict standards as far as their active ingredients, they often are of a different color, size, or shape than their `brand name’ equivalents.
As it turns out, patients in this study were far less likely to refill, and take, dissimilar looking generic drugs, than they were the brand name drug.
First a link to the abstract (the full article is behind a pay wall), then some excerpts from the press release, after which I’ll return with a little more.
Original Investigation | ONLINE FIRST
Variations in Pill Appearance of Antiepileptic Drugs and the Risk of Nonadherence
Aaron S. Kesselheim, MD, JD, MPH; Alexander S. Misono, MD, MBA; William H. Shrank, MD, MSHS; Jeremy A. Greene, MD, PhD; Michael Doherty; Jerry Avorn, MD; Niteesh K. Choudhry, MD, PhD
Arch Intern Med. 2012;():1-7. doi:10.1001/2013.jamainternmed.997.
Background
Generic prescription drugs are bioequivalent to brand-name versions but may not have consistent color or shape, which can cause confusion and lead to interruptions in medication use. We sought to determine whether switching among different-appearing antiepileptic drugs (AEDs) is associated with increased rates of medication nonpersistence, which can have serious medical, financial, and social consequences.
<SNIP>
Conclusions
Changes in pill color significantly increase the odds of nonpersistence; this may have important clinical implications. Our study supports a reconsideration of current regulatory policy that permits wide variation in the appearance of bioequivalent drugs.
And the press release from Brigham and Women's Hospital.
Differences in generic pill characteristics may lead to interruptions in essential medication use
Changes in pill appearance significantly increase the odds that patients will stop taking their drugs as prescribed
Boston, MA—Generic medications currently account for over 70 percent of prescriptions dispensed. However, while generic drugs are clinically bioequivalent to the brand-name version, they often differ in their physical characteristics, such as color and shape. Researchers from Brigham and Women's Hospital (BWH) have found that some patients who receive generic drugs that vary in their color are over 50 percent more likely to stop taking the drug, leading to potentially important and potentially adverse clinical effects.
The study will be published electronically on December 31, 2012 in the Archives of Internal Medicine.
"Pill appearance has long been suspected to be linked to medication adherence, yet this is the first empirical analysis that we know of that directly links pills' physical characteristics to patients' adherence behavior," explained Aaron S. Kesselheim MD, JD, MPH, assistant professor of medicine in the Division of Pharmacoepidemiology and Pharmacoeconomics at BWH, and principal investigator of this study. "We found that changes in pill color significantly increase the odds that patients will stop taking their drugs as prescribed."
The researchers conducted a case-control study of patients taking antiepileptic drugs and compared the odds that patients who did not refill their medication had been given pills that differed in color or shape from the prior prescriptions. Using a large national database of filled prescriptions, when the researchers identified a break in the patient's use of the drug, they looked at the previous two prescription fillings to see if they were the same color and shape. They found that interruptions in the prescription filling occurred significantly more frequently when the pills had different color. Interruptions in antiepileptic drug use for even a few days can raise the risk of seizure and have important medical and social consequences for patients.
Somewhat connected to all of this are studies that have shown that the color, size, and shape of a pill (including placebos) has an effect on the the patient’s perception of how well they work.
In a 1996 edition of the BMJ, we find:
Effect of colour of drugs: systematic review of perceived effect of drugs and of their effectiveness.
A. J. de Craen, P. J. Roos, A. Leonard de Vries, and J. Kleijnen
RESULTS: The studies on perceived action of coloured drugs showed that red, yellow, and orange are associated with a stimulant effect, while blue and green are related to a tranquillising effect. The trials that assessed the impact of the colour of drugs on their effectiveness showed inconsistent differences between colours. The quality of the methods of these trials was variable. Hypnotic, sedative, and anxiolytic drugs were more likely than antidepressants to be green, blue, or purple.
CONCLUSIONS: Colours affect the perceived action of a drug and seem to influence the effectiveness of a drug. Moreover, a relation exists between the colouring of drugs that affect the central nervous system and the indications for which they are used. Research contributing to a better understanding of the effect of the colour of drugs is warranted.
Other research has shown that – with placebos – shots are deemed more effective than oral drugs, and capsules are perceived as being more effective than pills.
From a much earlier study, we get an idea of the pre-conceived notions that many patients have regarding pill color:
Percept Mot Skills. 1979 Oct;49(2):367-72.
Classification of placebo drugs: effect of color.
Jacobs KW, Nordan FM.
Abstract
To study the role of color in the pscyhological effects of placebo drugs, 100 subjects were asked to place each of six different colored capsules into one of three classifications of drug effects. Results indicate that red and yellow placebos are classified as stimulants while blue placebos are classified as depressants.
While the color of a pill may seem irrelevant to many people, the non-adherence of patients to their prescribed medications costs the health care system hundreds of billions of dollars each year.
NEHI Research Shows Patient Medication Nonadherence Costs Health Care System $290 Billion Annually
August 11, 2009
CAMBRIDGE, MA – The New England Healthcare Institute (NEHI) today released new research showing that patients who do not take their medications as prescribed by their doctors cost the U.S. health care system an estimated $290 billion in avoidable medical spending every year. NEHI, a nonprofit health policy organization, recommends four key actions that can best improve medication adherence.
Given the human, and economic costs of non-adherent patients, there may very well be substantial benefits to applying `pill psychology’ to generic prescription drug design.
